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The purpose of this study is to explore whether a non-invasive form of ear stimulation called transcutaneous auricular vagus nerve stimulation (taVNS) can change the way participants perceive pain. Investigators will recruit up to 20 participants with chronic post-stroke upper extremity pain. The goal is to determine if there is a pain reduction after ear stimulation.
In this study, investigators main goal is to establish transcutaneous auricular vagus nerve stimulation (taVNS) as an effective non-invasive neuromodulation method for analgesia of post-stroke upper extremity pain. Participants are required to have an ischemic or hemorrhagic stroke that occurred at least 6 months prior and are currently suffering upper extremity pain. Each participant will undergo an in-person visit. Participants will first finish the pain questionnaires and have quantitative sensory testing (QST) conducted to determine baseline pain thresholds. Participants will then receive 30 minutes of taVNS (either active or sham). Upon the completion of the stimulation intervention, participants will then be tested for another QST and pain questionnaires.
Aim 1: Test the safety and feasibility of taVNS in participants with chronic post-stroke upper extremity pain.
Over the last 8 years, investigators have demonstrated that taVNS is safe and feasible in several different populations in our previous studies. Specifically, investigators have demonstrated that taVNS is well tolerated and safe for participants with chronic stroke in our previous clinical trial. In this study, investigators will further verify the safety and feasibility of taVNS in the population with chronic post-stroke upper extremity pain.
Aim 2: Investigate whether taVNS can modulate pain in this population compared to sham.
In this single-visit, double-blinded, sham-controlled pilot trial, investigators will compare changes in post-stroke upper extremity pain scores and pain threshold derived from QST before and after a 30-minute taVNS intervention, as well as between active and sham taVNS. The findings will help investigators understand whether taVNS can modulate pain in this population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Auricular Neurostimulation (Active) | Active Comparator | Participants will receive auricular stimulation of both the 15Hz on cymba conchae and 100Hz on tragus. |
|
| Auricular Neurostimulation (Sham) | Sham Comparator | Participants will receive auricular stimulation of 15Hz on their earlobe. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) | Device | The intervention applied is called transcutaneous auricular vagus nerve stimulation (taVNS) which administers electrical stimulation at the ear which targets the auricular branch of the vagus nerve. |
| Measure | Description | Time Frame |
|---|---|---|
| Thermal Pain Threshold | Using a quantitative sensory testing paradigm, the investigators will systematically determine information on thermal pain tolerance thresholds (degrees celsius) using a 30 × 30 mm thermode attached to the left forearm of participants. | assessed during and immediately after the single 30-minute taVNS session, Post 30-minute taVNS reported |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Pain Ratings | Participants will rate their post-stroke upper extremity pain intensity before and after the taVNS using a standard numeric pain rating scale (from minimum 0 to maximum 10, higher scores mean more pain). | assessed during and immediately after the single 30-minute taVNS session, Post 30-minute taVNS reported |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina Institute of Psychiatry | Charleston | South Carolina | 29425 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41543462 | Derived | Peng X, Cox SS, Baker-Vogel B, Omonije F, Tucker K, Huttig B, Sutton F, Cash N, Wood M, Kautz SA, Badran BW, Borckardt JJ. Transcutaneous Auricular Neurostimulation Modulates Pain Perception in Survivors of Stroke With Chronic Upper-Extremity Pain: A Randomized, Sham-Controlled Pilot Study. Neuromodulation. 2026 Jun;29(4):607-615. doi: 10.1016/j.neurom.2025.12.005. Epub 2026 Jan 16. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Auricular Neurostimulation (Active) | Participants will receive auricular stimulation of both the 15Hz on cymba conchae and 100Hz on tragus. |
| FG001 | Auricular Neurostimulation (Sham) | Participants will receive auricular stimulation of 15Hz on their earlobe. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Auricular Neurostimulation (Active) | Participants will receive auricular stimulation of both the 15Hz on cymba conchae and 100Hz on tragus. |
| BG001 | Auricular Neurostimulation (Sham) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Thermal Pain Threshold | Using a quantitative sensory testing paradigm, the investigators will systematically determine information on thermal pain tolerance thresholds (degrees celsius) using a 30 × 30 mm thermode attached to the left forearm of participants. | Posted | Mean | Standard Deviation | Celsius | assessed during and immediately after the single 30-minute taVNS session, Post 30-minute taVNS reported |
|
up to 3 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Auricular Neurostimulation (Active) | Participants will receive auricular stimulation of both the 15Hz on cymba conchae and 100Hz on tragus. |
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This study was an early proof-of-concept pilot trial designed to establish safety and feasibility for tAN in individuals with chronic PSP. This study has a relatively small sample size, and future studies should be adequately powered to more clearly determine the clinical efficacy of tAN.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Xiaolong Peng | Medical University of South Carolina | 8437928642 | pengxi@musc.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 28, 2024 | Jul 21, 2025 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D010146 | Pain |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Sham Auricular Stimulation | Device | The sham auricular stimulation administers electrical stimulation at the ear lobe which has less auricular branch of the vagus nerve. |
|
Participants will receive auricular stimulation of 15Hz on their earlobe.
| BG002 | Total | Total of all reporting groups |
| year |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| QST Thermal Pain Threshold | One participant from the sham group did not complete the QST procedure correctly and was therefore excluded from the analysis. | Mean | Standard Deviation | Celsius |
|
| Subject Pain Rating | One participant from the sham group did not complete the QST procedure correctly and was therefore excluded from the analysis. | Mean | Standard Deviation | scale 0-10 |
|
|
|
| Secondary | Subjective Pain Ratings | Participants will rate their post-stroke upper extremity pain intensity before and after the taVNS using a standard numeric pain rating scale (from minimum 0 to maximum 10, higher scores mean more pain). | Posted | Mean | Standard Deviation | Scale 0-10 | assessed during and immediately after the single 30-minute taVNS session, Post 30-minute taVNS reported |
|
|
|
| 0 |
| 7 |
| 0 |
| 7 |
| 0 |
| 7 |
| EG001 | Auricular Neurostimulation (Sham) | Participants will receive auricular stimulation of 15Hz on their earlobe. | 0 | 8 | 0 | 8 | 0 | 8 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
|
| More than one race |
|
| Unknown or Not Reported |
|